Matritech regulatory update

The FDA's Immunology Devices Advisory Committee recommended approval of the Matritech NMP22 Test Kit to identify patients at risk of recurrence of bladder cancer on the condition that the company provide the agency with data on an additional number of subjects.

The company won't know whether it needs to run an additional trial of the urine assay until it completes a reanalysis of its clinical data and meets with the FDA. The company expects to meet with the agency in one to two weeks. ...